Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388785
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-25
Brief Title:
A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Post-vaccination Surveillance for Monitoring the Adverse Events Following Immunisation With QDENGA in a Real-world Setting in Malaysia PRIME-Q
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME-Q
Brief Summary:
The main aim of this study is to collect the number and type of medical problems adverse events after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever
No vaccination will be given as part of this study The study will only collect data of persons already vaccinated with QDENGA who agree to participate
No vaccination will be given as part of this study The study will only collect data of persons already vaccinated with QDENGA who agree to participate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None